NCT01767558

PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

Detailed description

10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. Subjects will undergo an ablation for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI and neurological exam will be conducted if the subject had a positive MRI at pre-hospital discharge.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Ablation / MRI	All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter. MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-01-14
• Last updated: 2018-09-19

Locations

11 sites across 6 countries: Belgium, France, Germany, Hungary, Netherlands, United Kingdom